SERENA P GB-R04 del 03-07-17
00/Per Bertani/Manuali d’uso Serena/ Serena con stampante
7/99
1.2 EUROPEAN STANDARDS AND DIRECTIVES APPLICABLE
SERENA 18/23 sterilizer complies with the following European Directives:
93/42/CEE and s.m.i. Medical Devices Directive, IIb Class, in accordance with the rule 15
– Appendix IX of the
above Directive.
2014/68/UE (PED
– Pressure Equipment Directive) on the sterilization chambers projected and realized in
accordance with Category I with evaluation form A.
2002/96/CEE (RAEE) on the disposal of shares from electrical or electronic components.
EN13060 current edition concerning performance requirement for small steam sterilizers
EN 61010-1 and 61010-2-40 current edition concerning
safety requirements for small steam sterilizers.
EN 62304 Software certification current edition
EN 61326 Electromagnetic Compatibility current edition
1.3 EXPECTED USAGE
Sterilizers SERENA are "steam sterilizers" fully automatic, which generate steam by heating elements.
SERENA sterilizers are used for the sterilization of surgical instruments
The load types that can be sterilized by the sterilizer SERENA are described in Table 1 of the reference technical
standard EN 13060. These loads include solid, porous, hollow type A and B, unwrapped, wrapped in single and
double envelope.. They are also used for materials and tools that can come into contact with blood and / or body
fluids.
Usage environments may be: hospitals, education or medical clinics, dental offices, veterinary.
Sterilizers REVERBERI can not be used to sterilize liquids or pharmaceutical products.
Do not use the machine for purposes other than those for which it was created. It
is important to ensure that the value of ground resistance is efficient and well
coordinated with the electrical protections of the implant, in order to avoid
electrical interferences to the autoclave.
1.4 SYMBOLS SHOWN ON THE STERILIZER
Consult the following table whenever a symbol below appears on the sterilizer or on the Manual.
WARNING
It shows a notice or a warning about the key functions or about
useful information. Pay close attention to blocks of text indicated
by this symbol.
OBSERVATION
The User is required to detect a measure value, to check an alert,
etc.
PROHIBITION
Any procedures that staff must not perform because, otherwise,
might endanger his own safety and that of others
OBLIGATION
Any procedures that staff must perform because, otherwise, might
endanger his own safety and that of others
CAUTION, IT IDENTIFIES A SOURCE OF HEAT, THERE MAY BE AN UNSAFE
TEMPERATURE
CAUTION, IT IDENTIFIES A GENERIC DANGER, THERE MAY BE A DANGEROUS
SITUATION
IT IDENTIFIES THE PROTECTIVE EARTH TERMINAL
